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510(k) K812050

KALLESTAD ANTISERA TO GENTAMICIN by Kallestad Laboratories, Inc. — Product Code DJI

K812050 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "KALLESTAD ANTISERA TO GENTAMICIN". The FDA issued a decision of Substantially Equivalent on August 3, 1981. The device falls under product code DJI (Antiserum, Gentamicin), a Class II device regulated under 21 CFR 862.3450. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1981
Date Received
July 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

Other clearances by Kallestad Laboratories, Inc.

  • K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM (December 3, 1986)
  • K862917 — PATHFINDER ROTAVIRUS CHEMILUMINESCENT (October 22, 1986)
  • K863682 — PATHFINDER(TM) SPECIMEN COLLECTION KIT (October 10, 1986)
  • K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS (September 29, 1986)
  • K862313 — KALLESTAD SM/RNP TEST REAGENT (August 6, 1986)
  • K862710 — KALLESTAD SSA/SSB ENA TEST REAGENTS (July 29, 1986)
  • K855014 — QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A (March 14, 1986)
  • K855010 — QUANTIMETRIC PLUS IGM REAGENT KIT (February 28, 1986)
  • K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT (February 26, 1986)
  • K855013 — QUANTIMETRIC PLUS SUPPORT PACK (February 26, 1986)

FDA data resources